The following data is part of a premarket notification filed by Delphinus Medical Technologies, Inc with the FDA for Solfvue.
| Device ID | K142517 |
| 510k Number | K142517 |
| Device Name: | SolfVue |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | DELPHINUS MEDICAL TECHNOLOGIES, INC 46701 COMMERCE CENTER DRIVE Plymouth, MI 48170 |
| Contact | Andrea N Wallen-gerding |
| Correspondent | Andrea N Wallen-gerding DELPHINUS MEDICAL TECHNOLOGIES, INC 46701 COMMERCE CENTER DRIVE Plymouth, MI 48170 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-08 |
| Decision Date | 2014-10-31 |
| Summary: | summary |